NEWS
BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has reached alignment with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn, a therapy for amyotrophic lateral sclerosis (ALS). This development follows the FDA’s Special Protocol Assessment (SPA) agreement granted in April 2024, which provided clarity on the trial design and endpoints. The Type C meeting resolved all outstanding CMC questions, allowing BrainStorm to proceed with the pivotal trial. Chaim Lebovits, CEO, expressed satisfaction with the outcome, emphasizing the importance of alignment in manufacturing complexities and the company's commitment to advancing ALS treatment.
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